Apalutamide and Overall Survival in Prostate Cancer

Matthew R. Smith; Fred Saad; Simon Chowdhury; Stéphane Oudard; Boris A. Hadaschik; Julie N. Graff; David Olmos; Paul N. Mainwaring; Ji Youl Lee; Hiroji Uemura; Peter De Porre; Andressa A. Smith; Sabine D. Brookman-May; Susan Li; Ke Zhang; Brendan Rooney; Angela Lopez-Gitlitz; Eric J. Small

doi:10.1016/j.eururo.2020.08.011

Apalutamide and Overall Survival in Prostate Cancer

Matthew R. Smith, Fred Saad, Simon Chowdhury, Stéphane Oudard, Boris A. Hadaschik, Julie N. Graff, David Olmos, Paul N. Mainwaring, Ji Youl Lee, Hiroji Uemura, Peter De Porre, Andressa A. Smith, Sabine D. Brookman-May, Susan Li, Ke Zhang, Brendan Rooney, Angela Lopez-Gitlitz, Eric J. Small

Knight Cancer Institute

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Apalutamide increased overall survival and delayed time to initiation of cytotoxic chemotherapy versus placebo in patients with nonmetastatic castration-resistant prostate cancer. Prior analyses had demonstrated clinically impactful improvement in metastasis-free survival, time to symptomatic progression, and second progression-free survival with apalutamide.

Original language	English (US)
Pages (from-to)	150-158
Number of pages	9
Journal	European Urology
Volume	79
Issue number	1
DOIs	https://doi.org/10.1016/j.eururo.2020.08.011
State	Published - Jan 2021

Keywords

Apalutamide
Nonmetastatic castration-resistant prostate cancer
Overall survival
Subsequent therapy
Time to cytotoxic chemotherapy

ASJC Scopus subject areas

Urology

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10.1016/j.eururo.2020.08.011

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Smith, M. R., Saad, F., Chowdhury, S., Oudard, S., Hadaschik, B. A., Graff, J. N., Olmos, D., Mainwaring, P. N., Lee, J. Y., Uemura, H., De Porre, P., Smith, A. A., Brookman-May, S. D., Li, S., Zhang, K., Rooney, B., Lopez-Gitlitz, A., & Small, E. J. (2021). Apalutamide and Overall Survival in Prostate Cancer. European Urology, 79(1), 150-158. https://doi.org/10.1016/j.eururo.2020.08.011

Apalutamide and Overall Survival in Prostate Cancer. / Smith, Matthew R.; Saad, Fred; Chowdhury, Simon; Oudard, Stéphane; Hadaschik, Boris A.; Graff, Julie N.; Olmos, David; Mainwaring, Paul N.; Lee, Ji Youl; Uemura, Hiroji; De Porre, Peter; Smith, Andressa A.; Brookman-May, Sabine D.; Li, Susan; Zhang, Ke; Rooney, Brendan; Lopez-Gitlitz, Angela; Small, Eric J.

In: European Urology, Vol. 79, No. 1, 01.2021, p. 150-158.

Research output: Contribution to journal › Article › peer-review

Smith, Matthew R. ; Saad, Fred ; Chowdhury, Simon ; Oudard, Stéphane ; Hadaschik, Boris A. ; Graff, Julie N. ; Olmos, David ; Mainwaring, Paul N. ; Lee, Ji Youl ; Uemura, Hiroji ; De Porre, Peter ; Smith, Andressa A. ; Brookman-May, Sabine D. ; Li, Susan ; Zhang, Ke ; Rooney, Brendan ; Lopez-Gitlitz, Angela ; Small, Eric J. / Apalutamide and Overall Survival in Prostate Cancer. In: European Urology. 2021 ; Vol. 79, No. 1. pp. 150-158.

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title = "Apalutamide and Overall Survival in Prostate Cancer",

abstract = "Apalutamide increased overall survival and delayed time to initiation of cytotoxic chemotherapy versus placebo in patients with nonmetastatic castration-resistant prostate cancer. Prior analyses had demonstrated clinically impactful improvement in metastasis-free survival, time to symptomatic progression, and second progression-free survival with apalutamide.",

keywords = "Apalutamide, Nonmetastatic castration-resistant prostate cancer, Overall survival, Subsequent therapy, Time to cytotoxic chemotherapy",

author = "Smith, {Matthew R.} and Fred Saad and Simon Chowdhury and St{\'e}phane Oudard and Hadaschik, {Boris A.} and Graff, {Julie N.} and David Olmos and Mainwaring, {Paul N.} and Lee, {Ji Youl} and Hiroji Uemura and {De Porre}, Peter and Smith, {Andressa A.} and Brookman-May, {Sabine D.} and Susan Li and Ke Zhang and Brendan Rooney and Angela Lopez-Gitlitz and Small, {Eric J.}",

note = "Funding Information: Financial disclosures : Matthew R. Smith certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Eric J. Small has had advisory roles for Fortis and Janssen Oncology; has received compensation for travel from Janssen; holds stock and interest in Fortis and Harpoon Therapeutics; has received honoraria from Janssen; and has received research funding from Janssen and Merck Sharp & Dohme. Fred Saad has had advisory roles for Astellas Pharma, AstraZeneca/MedImmune, Bayer, Janssen Oncology, and Sanofi; has received honoraria from AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Janssen Oncology, and Sanofi; and has received research funding grants provided to the institution from Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen Oncology, Pfizer, and Sanofi. Simon Chowdhury has had advisory roles for Astellas Pharma, Bayer, Clovis Oncology, Janssen-Cilag, and Pfizer; has served on speakers{\textquoteright} bureau for Pfizer; has received honoraria from Clovis Oncology and Novartis; and has received research funding from Clovis Oncology and Sanofi/Aventis. St{\'e}phane Oudard has had advisory roles for Astellas Pharma, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and Sanofi; has received compensation for travel from Bayer, Bristol Myers Squibb, Eisai, Merck Sharp & Dohme, Novartis, and Pfizer; has received honoraria from Astellas Pharma, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and Sanofi; and has received research funding from Ipsen and Sanofi. Boris A. Hadaschik has had advisory roles for ABX, Astellas, Bayer, Bristol Myers Squibb, Janssen R&D, Lightpoint Medical, Inc., and Pfizer; has received research funding from Astellas, Bristol Myers Squibb, German Cancer Aid, German Research Foundation, and Janssen R&D; and has received compensation for travel from Astellas, AstraZeneca, and Janssen R&D. Julie N. Graff has had an advisory role for Exelixis; has received compensation for travel from Bayer, Clovis Oncology, and Merck Sharp & Dohme; holds patents, royalties, and intellectual property with Oncoresponse: Exceptional Responders; has received honoraria from Astellas, Bayer, Janssen Oncology, and Medivation; and has received research funding from Bristol Myers Squibb, Janssen Oncology, Medivation, Merck Sharp & Dohme, and Sanofi. David Olmos has had advisory roles for AstraZeneca, Bayer, Clovis Oncology, Daiichi-Sankyo, Janssen, MSD, and Genentech/Roche; has received compensation for travel from Bayer, Ipsen, Janssen, and Genentech/Roche; has received honoraria from Bayer, Janssen, and Sanofi; and has received research funding from Astellas, AstraZeneca, Bayer, Genentech/Roche, Janssen, Pfizer, Medivation, MSD, Pfizer, and Tokai Pharmaceuticals. Paul N. Mainwaring has had an advisory role with Pfizer; has participated in speakers{\textquoteright} bureau with Astellas, Ipsen, Janssen Oncology, Medivation, Merck Sharp & Dohme, Novartis, Pfizer, and Roche/Genentech; has received compensation for travel from Astellas, Ipsen, Janssen Oncology, Medivation, Merck Sharp & Dohme, Novartis, Pfizer, and Roche/Genentech; holds stock and interests with Xing Technologies; has received honoraria from Astellas, Ipsen, Janssen Oncology, Medivation, Merck Sharp & Dohme, and Novartis, Pfizer, and Roche/Genentech; and has received research funding from Merck KGaA. Funding Information: Ji Youl Lee declares no conflicts of interest. Hiroji Uemura has had advisory roles for AstraZeneca, Bayer, Janssen, and Takeda; has received compensation for travel from Astellas, Bayer, and Janssen; has received honoraria from Astellas, AstraZeneca, Bayer, FRI-Toyama chem., Janssen, Kyowa-Kirin, Sanofi, and Takeda; and has received research funding from Bayer, Chugai Pharmaceuticals, FRI-Toyama chem., Sanofi, Taiho, and Takeda. Peter De Porre, Andressa A. Smith, Sabine D. Brookman May, Susan Li, Ke Zhang, Brendan Rooney, and Angela Lopez-Gitlitz are current or former employees of Janssen Research & Development and hold/held stock in Johnson & Johnson. Matthew R. Smith has had advisory roles for Amgen, Bayer, Janssen Oncology, Lilly, Novartis, and Pfizer; has received compensation for travel from Amgen, Bayer, Janssen, and Lilly; and has received research funding from Bayer, Gilead Sciences, and Janssen Oncology. Funding Information: Funding/Support and role of the sponsor : The trial was designed by two of the academic authors and representatives of the Aragon Pharmaceuticals. The sponsor commissioned an independent data and safety monitoring committee to review safety data the results of the primary efficacy analysis before unblinding. Data were transcribed, by trial personnel at each clinical site, from source documents into electronic case-report forms prepared by the sponsor. All the authors had access to the data, drafted the manuscript with input from the sponsor (Janssen), reviewed and approved the manuscript before submission, and made the decision to submit the manuscript for publication. The SPARTAN study was funded by Janssen Research & Development . Janssen Global Services, LLC provided funding for editorial assistance. Funding Information: Acknowledgements: The authors would like to thank the patients who participated in this trial, and their families, as well as the investigators, study coordinators, study teams, and nurses. Editorial assistance was provided by William Turner, PhD, of Parexel, with funding from Janssen Global Services, LLC. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu . ",

year = "2021",

month = jan,

doi = "10.1016/j.eururo.2020.08.011",

language = "English (US)",

volume = "79",

pages = "150--158",

journal = "European Urology",

issn = "0302-2838",

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TY - JOUR

T1 - Apalutamide and Overall Survival in Prostate Cancer

AU - Smith, Matthew R.

AU - Saad, Fred

AU - Chowdhury, Simon

AU - Oudard, Stéphane

AU - Hadaschik, Boris A.

AU - Graff, Julie N.

AU - Olmos, David

AU - Mainwaring, Paul N.

AU - Lee, Ji Youl

AU - Uemura, Hiroji

AU - De Porre, Peter

AU - Smith, Andressa A.

AU - Brookman-May, Sabine D.

AU - Li, Susan

AU - Zhang, Ke

AU - Rooney, Brendan

AU - Lopez-Gitlitz, Angela

AU - Small, Eric J.

N1 - Funding Information: Financial disclosures : Matthew R. Smith certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Eric J. Small has had advisory roles for Fortis and Janssen Oncology; has received compensation for travel from Janssen; holds stock and interest in Fortis and Harpoon Therapeutics; has received honoraria from Janssen; and has received research funding from Janssen and Merck Sharp & Dohme. Fred Saad has had advisory roles for Astellas Pharma, AstraZeneca/MedImmune, Bayer, Janssen Oncology, and Sanofi; has received honoraria from AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Janssen Oncology, and Sanofi; and has received research funding grants provided to the institution from Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen Oncology, Pfizer, and Sanofi. Simon Chowdhury has had advisory roles for Astellas Pharma, Bayer, Clovis Oncology, Janssen-Cilag, and Pfizer; has served on speakers’ bureau for Pfizer; has received honoraria from Clovis Oncology and Novartis; and has received research funding from Clovis Oncology and Sanofi/Aventis. Stéphane Oudard has had advisory roles for Astellas Pharma, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and Sanofi; has received compensation for travel from Bayer, Bristol Myers Squibb, Eisai, Merck Sharp & Dohme, Novartis, and Pfizer; has received honoraria from Astellas Pharma, Bayer, Bristol Myers Squibb, Eisai, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and Sanofi; and has received research funding from Ipsen and Sanofi. Boris A. Hadaschik has had advisory roles for ABX, Astellas, Bayer, Bristol Myers Squibb, Janssen R&D, Lightpoint Medical, Inc., and Pfizer; has received research funding from Astellas, Bristol Myers Squibb, German Cancer Aid, German Research Foundation, and Janssen R&D; and has received compensation for travel from Astellas, AstraZeneca, and Janssen R&D. Julie N. Graff has had an advisory role for Exelixis; has received compensation for travel from Bayer, Clovis Oncology, and Merck Sharp & Dohme; holds patents, royalties, and intellectual property with Oncoresponse: Exceptional Responders; has received honoraria from Astellas, Bayer, Janssen Oncology, and Medivation; and has received research funding from Bristol Myers Squibb, Janssen Oncology, Medivation, Merck Sharp & Dohme, and Sanofi. David Olmos has had advisory roles for AstraZeneca, Bayer, Clovis Oncology, Daiichi-Sankyo, Janssen, MSD, and Genentech/Roche; has received compensation for travel from Bayer, Ipsen, Janssen, and Genentech/Roche; has received honoraria from Bayer, Janssen, and Sanofi; and has received research funding from Astellas, AstraZeneca, Bayer, Genentech/Roche, Janssen, Pfizer, Medivation, MSD, Pfizer, and Tokai Pharmaceuticals. Paul N. Mainwaring has had an advisory role with Pfizer; has participated in speakers’ bureau with Astellas, Ipsen, Janssen Oncology, Medivation, Merck Sharp & Dohme, Novartis, Pfizer, and Roche/Genentech; has received compensation for travel from Astellas, Ipsen, Janssen Oncology, Medivation, Merck Sharp & Dohme, Novartis, Pfizer, and Roche/Genentech; holds stock and interests with Xing Technologies; has received honoraria from Astellas, Ipsen, Janssen Oncology, Medivation, Merck Sharp & Dohme, and Novartis, Pfizer, and Roche/Genentech; and has received research funding from Merck KGaA. Funding Information: Ji Youl Lee declares no conflicts of interest. Hiroji Uemura has had advisory roles for AstraZeneca, Bayer, Janssen, and Takeda; has received compensation for travel from Astellas, Bayer, and Janssen; has received honoraria from Astellas, AstraZeneca, Bayer, FRI-Toyama chem., Janssen, Kyowa-Kirin, Sanofi, and Takeda; and has received research funding from Bayer, Chugai Pharmaceuticals, FRI-Toyama chem., Sanofi, Taiho, and Takeda. Peter De Porre, Andressa A. Smith, Sabine D. Brookman May, Susan Li, Ke Zhang, Brendan Rooney, and Angela Lopez-Gitlitz are current or former employees of Janssen Research & Development and hold/held stock in Johnson & Johnson. Matthew R. Smith has had advisory roles for Amgen, Bayer, Janssen Oncology, Lilly, Novartis, and Pfizer; has received compensation for travel from Amgen, Bayer, Janssen, and Lilly; and has received research funding from Bayer, Gilead Sciences, and Janssen Oncology. Funding Information: Funding/Support and role of the sponsor : The trial was designed by two of the academic authors and representatives of the Aragon Pharmaceuticals. The sponsor commissioned an independent data and safety monitoring committee to review safety data the results of the primary efficacy analysis before unblinding. Data were transcribed, by trial personnel at each clinical site, from source documents into electronic case-report forms prepared by the sponsor. All the authors had access to the data, drafted the manuscript with input from the sponsor (Janssen), reviewed and approved the manuscript before submission, and made the decision to submit the manuscript for publication. The SPARTAN study was funded by Janssen Research & Development . Janssen Global Services, LLC provided funding for editorial assistance. Funding Information: Acknowledgements: The authors would like to thank the patients who participated in this trial, and their families, as well as the investigators, study coordinators, study teams, and nurses. Editorial assistance was provided by William Turner, PhD, of Parexel, with funding from Janssen Global Services, LLC. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu .

PY - 2021/1

Y1 - 2021/1

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AB - Apalutamide increased overall survival and delayed time to initiation of cytotoxic chemotherapy versus placebo in patients with nonmetastatic castration-resistant prostate cancer. Prior analyses had demonstrated clinically impactful improvement in metastasis-free survival, time to symptomatic progression, and second progression-free survival with apalutamide.

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KW - Nonmetastatic castration-resistant prostate cancer

KW - Overall survival

KW - Subsequent therapy

KW - Time to cytotoxic chemotherapy

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